Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Assisted Bronchoscopy With Subsequent Surgical Resection (CRONOS-CH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System
研究概览
简要总结
The purpose of this study is to confirm the procedural feasibility and device usability of the HybridTherm® system during bronchoscopic cryo-assisted radiofrequency ablation (RFA) performed prior to scheduled surgical resection in patients with lung cancer. The bronchoscopy session includes tumor ablation and, when clinically indicated, mediastinal lymph node staging by EBUS-TBNA.
详细描述
This is a prospective, single-arm, post-market clinical investigation conducted in Switzerland to collect clinical data on the use, safety, and performance of the CE-marked HybridTherm® system during routine bronchoscopic tumor management procedures. The investigation is classified as a ClinO-MD Category A1 medical device study, as the HybridTherm® system is CE-marked and used strictly within its intended purpose under normal conditions of clinical use.
The investigation is investigator-initiated and single-center, conducted at the University Hospital Zurich. The Sponsor-Investigator is responsible for the initiation, conduct, management, safety oversight, and data handling of the study in accordance with the Swiss Human Research Act (HRA), the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), ISO 14155, and applicable ethical requirements. Ethics Committee approval is required prior to study initiation, and the investigation will begin only after a positive written decision from the competent cantonal ethics committee has been obtained.
The HybridTherm® system is a bipolar cryo-cooled radiofrequency ablation device intended for incision, coagulation, and ablation of tissue during flexible endoscopic procedures in the tracheobronchial system. The system provides internally cooled radiofrequency energy to delay tissue desiccation and impedance rise, thereby enabling controlled energy delivery during ablation. In this investigation, the device is used during clinically indicated bronchoscopic procedures without deviation from its approved indication or standard clinical workflow.
All enrolled participants undergo diagnostic bronchoscopy as part of routine clinical care, including mediastinal lymph node staging when clinically indicated. Transbronchial cryo-assisted radiofrequency ablation is performed during the same bronchoscopy session under general anesthesia. Surgical resection of the targeted lung lesion follows according to the established oncologic treatment plan and is not altered by study participation. No randomization, blinding, or comparator intervention is included.
Data collected in this investigation are derived exclusively from standard-of-care procedures, routine imaging, device readouts, and histopathological assessment of resected specimens. No additional diagnostic tests, therapeutic interventions, or protocol-mandated procedures beyond routine clinical practice are introduced. All analyses are descriptive in nature and are intended to support post-market evaluation of procedural feasibility, safety, and device usability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who require diagnostic bronchoscopy for suspicious lung lesions with mediastinal lymph node status confirmed as NO by one of the following: Prior PET-CT showing no FDG-avid mediastinal lymph nodes, OR intraoperative EBUS-TBNA with ROSE confirming negative lymph nodes (performed when clinically indicated per section 6.1).
- •Solitary pulmonary lesions ≤ 2.5cm with histologically or cytologically confirmed primary lung cancer.
- •Suitable candidate for surgical resection of the tumor targeted for ablation
- •Interdisciplinary tumor board consent
- •Ability to read, understand, and sign patient Informed Consent Form (ICF)
- •Age ≥ 18-years-old
- •≥ 20 mm of free space between the calculated intended ablation zone and the lung parenchyma or any critical structures (pleura, vessels and main bronchi).
排除标准
- •Pregnant or nursing (breast feeding) females
- •Central tumors abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea)
- •Thoracic electronic implants (e.g., pacemakers, ICDs)
- •Uncorrectable coagulopathy or platelet count ≤ 50,000/mm³
- •Patients receiving anticoagulant therapy or with pulmonary hypertension that, in the opinion of the Investigator, poses an unacceptable safety risk for bronchoscopy and ablation.
- •Severe, uncontrolled comorbidities
- •Active systemic infection
- •Prior radiation therapy (SBRT) in the intended ablation zone
- •Recent Investigational therapy within the last 30 days that the investigator deems could interfere with proceeding in the clinical investigation
- •Tumors associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis
- •Investigators determine that study participation poses safety risk
- •Any comorbidities judged by the principal Investigator to be contraindicated for bronchoscopy
- •Subject was judged unsuitable for study participation by the Investigator for any other reason
研究组 & 干预措施
HybridTherm Cryo-Assisted RFA & surgical resection
Participants undergo transbronchial cryo-assisted radiofrequency ablation (RFA) using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy. When clinically indicated, mediastinal lymph node staging by performed. Surgical resection of the treated lung lesion follows according to the standard clinical treatment plan.
干预措施: HybridTherm® System (Device)
结局指标
主要结局
Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System
时间窗: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
Successful device use, defined as the completion of ablation with the HybridTherm® system with investigator confirmation that the ablation zone achieved sufficient coverage based on intra-procedural imaging
Number of Participants with Bleeding-Related Serious Adverse Events Associated with the Investigational Device and/or RFA Procedure
时间窗: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Number of Serious Adverse Events (SAEs) associated with bleeding related to the investigational device and/or radiofrequency ablation (RFA) procedure.
Severity of Bleeding-Related Adverse Events as Assessed by the Nashville Bleeding Scale
时间窗: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Safety assessments for bleeding Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure, graded using the Nashville bleeding scale.
次要结局
- Total Number of Serious Adverse Events Related to the Investigational Device and/or RFA Procedure(From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure))
- Total Number of Adverse Events Related to the Investigational Device and/or RFA Procedure(From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure))
- Macroscopic and Microscopic Evidence of Ablation in the Resected Specimen(At Surgical Resection (7-14 Days Post-Procedure))
- Percentage of Tumor Necrosis Within the Ablation Zone(At Surgical Resection (7-14 Days Post-Procedure))
- Histopathologic Complete Response (Absence of Viable Tumor Cells) Within the Ablation Zone(At Surgical Resection (7-14 Days Post-Procedure))
- Composite Descriptive Intra-Procedural Metrics During Bronchoscopic Cryo-assisted RFA(Day 0 (Diagnostic Bronchoscopy and RFA Procedure))
研究者
Carolin Steinack
Head of Interventional Pulmonology, Sponsor, Principal Investigator
University of Zurich